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CAPSUCOVID: Capsule Endoscopy as an Alternative to Colonoscopy

Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Recruiting
CT.gov ID
NCT06031051
Collaborator
Medtronic (Industry)
704
Enrollment
4
Locations
1
Arm
35.3
Anticipated Duration (Months)
176
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.

Condition or Disease Intervention/Treatment Phase
  • Device: Pillcam Crohn's Capsule Endoscopy
 N/A

Detailed Description

Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy).

Study population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria

Study Design

Study Type:
Interventional
Anticipated Enrollment :
704 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?
Actual Study Start Date :
Dec 22, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Pillcam Crohn's Capsule Endoscopy and colonoscopy

All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy

Device: Pillcam Crohn's Capsule Endoscopy
Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy
Other Names:
  • Pillcam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. percentage of patients who could avoid colonoscopy [6 months]

      To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE

    Secondary Outcome Measures

    1. CE diagnostic yield and adenoma detection rate (ADR) [6 months]

      Number of adenoma detected by CE

    2. To compare CE and CC findings [6 months]

      Compare findings between both techniques

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years

    • Rectal bleeding/haematochezia in patients >50 years who have undergone a colonoscopy <5 years ago or <50 years with no risk factors for CRC

    • Chronic constipation/abdominal distension/abdominal pain/diarrhea

    • Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017) with no iFOBT performed

    • Recent change in bowel habits

    • Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary syndromes, CRC surgery, Inflammatory Bowel Disease

    Exclusion Criteria:

    • Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis

    • Evaluation following fragmented resection (recurrence ruled out)

    • Patients with a positive FIT

    • Pregnancy or breast-feeding

    • Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices.

    • Allergy or known contraindication to the medications and preparations agents used in the procedure.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital universitario de Santa Cruz de Tenerife Santa Cruz De Tenerife Canarias Spain
    2 Hospital clinic of barcelona Barcelona Spain 08036
    3 Hospital Sant Pau Barcelona Spain 08041
    4 Hospital Mutua de Terrassa Terrassa Spain

    Sponsors and Collaborators

    • Hospital Clinic of Barcelona
    • Medtronic

    Investigators

    • Principal Investigator: BEGOÑA GONZALEZ SUAREZ, MD PhD, Hospital Clinic of Barcelona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Begoña González Suárez, MD PhD, Hospital Clinic of Barcelona
    ClinicalTrials.gov Identifier:
    NCT06031051
    Other Study ID Numbers:
    • CAPSUCOVID
    First Posted:
    Sep 11, 2023
    Last Update Posted:
    Sep 11, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colonic Diseases

    Study Results

    No Results Posted as of Sep 11, 2023